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Nucynta ER Side Effects

Generic Name: tapentadol

Note: This document contains side effect information about tapentadol. Some of the dosage forms listed on this page may not apply to the brand name Nucynta ER.

For the Consumer

Applies to tapentadol: oral solution, oral tablet, oral tablet extended release

Along with its needed effects, tapentadol (the active ingredient contained in Nucynta ER) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking tapentadol:

Less common
  • Bladder pain
  • bloody or cloudy urine
  • body aches or pain
  • chills
  • cough
  • difficult, burning, or painful urination
  • difficulty with breathing
  • fever
  • headache
  • loss of voice
  • lower back or side pain
  • muscle aches
  • unusual tiredness or weakness
  • Anxiety
  • being forgetful or confused
  • clumsiness or unsteadiness
  • convulsions
  • drowsiness
  • fast or irregular heartbeat
  • feeling drunk
  • irritability or restlessness
  • joint pain, stiffness, or swelling
  • pale or blue lips, fingernails, or skin
  • rash, hives, or itching
  • sensation of heaviness
  • shakiness or trembling
  • slurred speech
  • swelling of the eyelids, face, lips, hands, or feet
  • tightness in the chest
  • trouble with speaking or hoarseness
  • troubled breathing or swallowing
Incidence not known
  • Changes in behavior
  • dizziness
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • seeing, hearing, or feeling things that are not there
  • thoughts of killing oneself

Some side effects of tapentadol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Less common
  • Abnormal dreams
  • decreased appetite
  • difficulty with moving
  • heartburn or indigestion
  • increased sweating
  • muscle pain or stiffness
  • redness of the face, neck, arms, and occasionally, upper chest
  • stomach discomfort, upset, or pain
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
  • Change in vision

For Healthcare Professionals

Applies to tapentadol: oral tablet, oral tablet extended release


The most common adverse reactions were nausea, dizziness, vomiting, constipation, headache, and somnolence.[Ref]


Very common (10% or more): Nausea (up to 30%), vomiting (up to 18%), constipation (up to 17%)
Common (1% to 10%): Dry mouth, dyspepsia, diarrhea, abdominal discomfort
Rare (less than 0.1%): Impaired gastric emptying[Ref]

Nervous system

Very common (10% or more): Dizziness (up to 24%), headache (up to 15%), somnolence (up to 15%)
Common (1% to 10%): Tremor, lethargy, vertigo, disturbance in attention, sedation, hypoesthesia
Uncommon (0.1% to 1%): Memory impairment, mental impairment, syncope, balance disorder, dysarthria, paresthesia, depressed level of consciousness, presyncope, ataxia
Rare (less than 0.1%): Convulsion, coordination abnormal
Frequency not reported: Seizure, serotonin syndrome[Ref]


Common (1% to 10%): Insomnia, confusion, abnormal dreams, anxiety, depression, irritability, nervousness, drug withdrawal syndrome, restlessness, sleep disorder, hallucination, depressed mood
Uncommon (0.1% to 1%): Disorientation, agitation, perception disturbances, euphoric mood, nightmare
Rare (less than 0.1%): Thinking abnormal, drug dependence
Postmarketing reports: Suicidal ideation, panic attack[Ref]


Common (1% to 10%): Fatigue, asthenia, chills, edema, feeling hot, feeling cold, feeling of body temperature change, mucosal dryness
Uncommon (0.1% to 1%): Feeling abnormal, feeling drunk, feeling of relaxation[Ref]


Common (1% to 10%): Pruritus, hyperhidrosis, pruritus generalized, rash, flushing
Uncommon (0.1% to 1%): Urticaria
Postmarketing reports: Angioedema[Ref]


Common (1% to 10%): Nasopharyngitis, upper respiratory tract infection, dyspnea
Uncommon (0.1% to 1%): Respiratory depression, oxygen saturation decreased, cough[Ref]


Common (1% to 10%): Hot flush, hypotension
Uncommon (0.1% to 1%): Heart rate increased, heart rate decreased, blood pressure decreased, palpitations, left bundle branch block[Ref]


Common (1% to 10%): Urinary tract infection, erectile dysfunction
Uncommon (0.1% to 1%): Urinary hesitation, pollakiuria, sexual dysfunction[Ref]


Common (1% to 10%): Myalgia, involuntary muscle contractions, muscle spasms
Uncommon (0.1% to 1%): Bone pain, sensation of heaviness[Ref]


Common (1% to 10%): Decreased appetite
Uncommon (0.1% to 1%): Weight decreased[Ref]


Common (1% to 10%): Vision blurred
Uncommon (0.1% to 1%): Visual disturbance[Ref]


Uncommon (0.1% to 1%): Hypersensitivity
Postmarketing reports: Anaphylaxis, anaphylactic shock[Ref]


Uncommon (0.1% to 1%): GGT increased, ALT increased, AST increased[Ref]


1. "Product Information. Nucynta (tapentadol)." PriCara Pharmaceuticals, Raritan, NJ.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

Some side effects of Nucynta ER may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.